Schizophrenia Clinical Trial
Official title:
Transcranial Weak Current Stimulation Treatments for Working Memory Dysfunction in Schizophrenia
Verified date | September 2023 |
Source | Herzog Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
For the present study, Investigators will examine the efficacy of active prefrontal anodal tDCS versus placebo (sham) interventions to treat WM dysfunction in schizophrenia. Investigators selected the prefrontal stimulation modality that proved most effective in enhancing high-load WM performance in single dose stimulation in healthy participants . The study employs a multi-stimulation approach, with 2 sessions per day for 5 consecutive days in the active treatment group (n=15) compared to a group that receives only sham stimulation (n=15). This preliminary approach is based upon findings of a recent study applying cathodal tDCS stimulation over left temporoparietal cortex (with left prefrontal anodal stimulation) for the treatment of persistent auditory hallucinations in schizophrenia. In a a recent study clinical benefits were maintained for at least 3 months following stimulation. In the present study, in addition to clinical outcome, researchers will evaluate whether similar improvement can be obtained with WM, EEG activity, and functional outcome (e.g., discharged from hospitalization following significant improvement or remission).
Status | Completed |
Enrollment | 33 |
Est. completion date | September 10, 2023 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Ages 18-75 - Primary diagnosis of DSM-IV schizophrenia (including schizoaffective disorder) - Right handed - Under stable doses of antipsychotic medication for =4 weeks - Normal vision by self report and physical exam - Use of effective method of birth control for women of childbearing capacity - Willing/capacity to provide informed consent - Outpatients or volunteering inpatients or involuntary patients with consent of legal guardian. Exclusion Criteria: - Current or past history of substance dependence or abuse (excluding nicotine) - Other current Axis I disorders - History of seizure, epilepsy in self or first degree relatives, stoke, brain surgery, head injury, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator) - Frequent and persistent migraines - History of adverse reaction to neurostimulation - Participation in study of investigational medication within 6 weeks - Pregnancy - Women who are breast-feeding - Current significant laboratory abnormality |
Country | Name | City | State |
---|---|---|---|
Israel | Herzog Medical Center | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Oded Meiron |
Israel,
Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091. Erratum In: Am J Psychiatry. 2012 Dec 1;169(12):1321. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in Positivie and Negative Syndrome Scale (PANSS, minimum score = 30, maximum score = 350, higher score indicate incresed ilness severity, lower scores indicate lower ilness severity) scores from baseline to post-tDCS intervention | change in total scores of the Positive and negative syndrome scale for Scizophrenia | Immediately after 10-day tDCS-intervention | |
Primary | change in working memory accuracy scores from baseline to post-tDCS intervention | change in verbal working memory accuracy (scores range from 0 to 126 correct responses) | Immediately after 10-day tDCS intervention | |
Primary | change in working memory reaction times from baseline to post-tDCS intervention | change in mean reaction times of correct rsponses (i.e., hits) (measures in millisecods range from 400 to 2000 msec) | Immediately after 10-day tDCS intervention | |
Secondary | change in Mismatch neagtivity (MMN) event related potentials from baseline to post-tDCS intervention | change in MMN amplitudes from baseline to post-tDCS intervention (change in microVolts: change of 1 to 5 microvolts undet Fz electrode | Imediatly after after 10-dat tDCS intervention | |
Secondary | change from baseline to post-tDCS intervention in Induced EEG theta power folowing verbal command | change in mean theta power activity (e.g., under Fz electrode, absolute power scale: µV2), change in mean absolute power of theta oscillations | Immediatly after tDCS intervention | |
Secondary | change from baseline to post-tDCS intervention in Induced EEG alpha power folowing verbal command | change in mean alpha power activity (e.g., under Fz electrode, absolute power scale: µV2), change in mean absolute power of alpha oscillations | Immediatly after tDCS intervention |
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